Endoscopic submucosal dissection hood

ABSTRACT

The present disclosure relates to the field of endoscopy. In particular, the present disclosure relates to systems and methods suitable for resecting or dissecting large areas of mucosal or submucosal tissue. The system may apply tension to and continuously manipulate mucosal tissue such that large lesions may be resected or dissected by a cutting element disposed at the distal end of an endoscope.

PRIORITY

This application is a continuation of U.S. patent application Ser. No.15/332,433, filed on Oct. 24, 2016, which claims the benefit of priorityunder 35 U.S.C. § 119 to U.S. Provisional Patent Application Ser. No.62/245,472, filed Oct. 23, 2015, which is incorporated by reference inits entirety and for all purposes.

FIELD

The present disclosure relates to the field of endoscopy. Specifically,the present disclosure relates to systems and methods useful forendoscopic submucosal dissection (ESD) and/or endoscopic mucosalresection (EMR). More specifically, the present disclosure relates to anendoscopic hood that provides enhanced visualization of the working areawithin which tissue engaging and tissue cutting elements operate todissect or resect mucosal and submucosal lesions.

BACKGROUND

Physicians have become increasingly willing to perform interventionaland therapeutic endoscopic procedures including, for example, fullthickness removal of large tissue lesions such as cancer, tunnelingunder the mucosal layer of the gastrointestinal (GI) tract orrespiratory system to treat submucosal tissues, repair of post-surgicalcomplications (e.g., post-surgical leaks, breakdowns of surgical staplelines and/or anastomotic leaks), thoracic surgery and airway/pleuralspace procedures. Specialized tools may be used to allow the physicianto perform these complex procedures faster and easier. A common way toincorporate these specialized tools onto the distal end of the endoscopeis through the use of endoscopic hoods or caps. The fullycircumferential design of currently available endoscopic hoods tends tohinder visualization of the target tissue and provide little workingspace for multiple tools to operate simultaneously. Althoughdouble-channel endoscopes may be available at some medical facilities,the individually articulating tools within each channel tend to beergonomically difficult to control, especially by a single physician.

SUMMARY

The present disclosure provides a high-visibility endoscope hood thatallows the medical professional to manipulate mucosal tissue such thatthe entire submucosal lesion is exposed for removal.

In one aspect, the present disclosure relates to an endoscopic systemcomprising: 1) an endoscope comprising an elongate body having aproximal end and a distal end and a working channel disposed within theelongate body; 2) an endoscopic hood coupled to the distal end of theendoscope, the endoscopic hood comprising: a first portion thatcomprises a proximal end, a distal end, and first and second lumensextending therebetween, wherein the first lumen is in open communicationwith the working channel of the endoscope; and a second portionextending from the distal end of the first portion, said second portioncomprising a wall and defining a working area adjacent a surface of thewall and the first lumen; 3) a first shaft having a proximal end and adistal end disposed within the working channel and the first lumen; and4) a second shaft having a proximal end and a distal end disposedalongside the elongate body and extending through the second lumen. Thewall may include a curved wall and the working area may be adjacent to aconcave surface of the curved wall and the first lumen. The curved wallmay include a variety of shapes, including, for example, a partialhollow conic section, a partial hollow cylinder or a partial hollowsphere. A cross-section of the wall may be in the form of an arc rangingfrom approximately 90 degrees to approximately 180 degrees. The wall maybe formed from a transparent material. The endoscopic system may furthercomprise a support member extending into the first lumen. The supportmember may define an aperture having a non-circular cross-sectionconfigured to slidably receive the first shaft. The first shaft may beslidably, but not rotationally, disposed within the working channel,first lumen and aperture. The distal end of the first shaft may includea shape memory material configured to assume a bent configuration whenunconstrained by an over-sheath or core wire. In addition, oralternatively, the distal end of the first shaft may be configured tobend upon actuation by an operation. The distal end of the first shaftmay further include a tissue cutting element. The second shaft may beslidably and rotationally disposed within the second lumen. The distalend of the second shaft may include a tissue engaging element. Rotatinga proximal end of the second shaft in a first direction may move thetissue engaging element towards the working area, and rotating aproximal end of the second shaft in a second direction may move thetissue engaging element away from the working area.

In another aspect, the present disclosure relates to an endoscopic hoodconfigured to be disposed at a distal end of an endoscope comprising anendoscope body and a working channel disposed within the endoscope body,the endoscopic hood comprising: 1) a first portion that comprises aproximal end, a distal end, and first and second lumens extendingtherebetween; and 2) a second portion extending from the distal end ofthe first portion, said second portion comprising a wall and defining aworking area adjacent the wall and the first lumen, wherein the firstlumen is configured to receive a shaft of a first device disposed in theworking channel of the endoscope, and wherein the second lumen isconfigured to receive a shaft of a second device disposed alongside anelongate body of the endoscope. The wall may include a curved wall andthe working area may be adjacent to a concave surface of the curved walland the first lumen. The curved wall may include a variety of shapes,including, for example, a partial hollow conic section, a partial hollowcylinder or a partial hollow sphere. A cross-section of the wall may bein the form of an arc ranging from approximately 90 degrees toapproximately 180 degrees. The wall may formed from a transparentmaterial. The endoscopic hood may further comprise a support memberextending into the first lumen. The support member may define anaperture having a non-circular cross-section.

In another aspect, the present disclosure relates to a method ofresecting or dissecting tissue comprising inserting the endoscopicsystem into a body lumen of a patient, positioning the endoscopic hoodof the endoscopic system over the surface of a target tissue, andresecting or dissecting the target tissue with the tissue cuttingelement while engaging the tissue with the tissue engaging element.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting embodiments of the present disclosure are described by wayof example with reference to the accompanying figures, which areschematic and not intended to be drawn to scale. In the figures, eachidentical or nearly identical component illustrated is typicallyrepresented by a single numeral. For purposes of clarity, not everycomponent is labeled in every figure, nor is every component of eachembodiment of the disclosure shown where illustration is not necessaryto allow those of ordinary skill in the art to understand thedisclosure. In the figures:

FIG. 1 provides a perspective view of an endoscopic hood, according toan embodiment of the present disclosure.

FIG. 2 provides a perspective view of the endoscopic hood of FIG. 1attached to the distal end of an endoscope in a delivery configurationaccording to an embodiment of the present disclosure.

FIGS. 3A-C provide a perspective view of the endoscopic hood andendoscope of FIG. 2 with the tissue cutting element deployed into theworking space defined by the endoscopic hood, according to the presentdisclosure.

FIGS. 4A-C provide an expanded view of the support member within thelumen of the endoscope hood (FIG. 4A-B) to guide the tissue cuttingelement (FIG. 4C) within the working space of the endoscopic hood,according to another embodiment of the present disclosure.

FIGS. 5A-C provide an alternative configuration of the support memberand tissue cutting element of FIGS. 4A-C.

FIG. 6 provides a side view of the control handle attached to theproximal end of the endoscope that allows the physician to manipulatethe tissue cutting element and tissue engaging element simultaneously,according to an embodiment of the present disclosure.

FIG. 7 provides schematic partial perspective view of an alternativedesign for the clip depicted in FIG. 2 attached to an endoscope,according to an embodiment of the present disclosure.

It is noted that the drawings are intended to depict only typical orexemplary embodiments of the disclosure. It is further noted that thedrawings may not be necessarily to scale. Accordingly, the drawingsshould not be considered as limiting the scope of the disclosure. Thedisclosure will now be described in greater detail with reference to theaccompanying drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Before the present disclosure is described in further detail, it is tobe understood that the disclosure is not limited to the particularembodiments described, as such may vary. It is also to be understoodthat the terminology used herein is for the purpose of describingparticular embodiments only, and is not intended to be limiting beyondthe scope of the appended claims. Unless defined otherwise, alltechnical terms used herein have the same meaning as commonly understoodby one of ordinary skill in the art to which the disclosure belongs.Finally, although embodiments of the present disclosure are describedwith specific reference to an endoscope hood attached to the distal endof an endoscope, it should be appreciated that the endoscope hooddisclosed herein may be attached to a variety of medical devices thatare inserted into a lumen of a patient, including for example, guidelumens, ports, optical wands and the like. As used herein, the term“distal” refers to the end farthest away from a medical professionalwhen introducing a device into a patient, while the term “proximal”refers to the end closest to the medical professional when introducing adevice into a patient.

In one embodiment, the present disclosure provides a system forperforming interventional and therapeutic procedures including, but notlimited to, removal of large lesions such as cancer, tunneling under themucosal layer of the GI or respiratory tract to treat submucosal tissuesand endoscopic repair of post-surgical complications such aspost-surgical leaks, breakdowns of surgical staple lines and/oranastomotic leaks. As illustrated in FIG. 1, in one embodiment thepresent disclosure includes an endoscopic hood 20 comprising a firstportion 21 with a proximal end 22, a distal end 23, and first 24 andsecond 25 lumens extending therebetween. The first lumen 24 isconfigured to receive a first shaft 40, and the second lumen 25 isconfigured to receive a second shaft 50 (FIG. 2). The endoscopic hood 20further includes a second portion 26 extending from the distal end 23 ofthe first portion 21. The second portion 26 may include a wall 27 thatdefines a working area 29 adjacent to the wall 27 and first lumen 24.The wall 27 may include a curvature that defines a concave inner surface28. For example, the concave inner surface 28 may include one or more ofa partially hollow conic section, a partially hollow cylinder or apartially hollow sphere, among other configurations. A cross-section ofthe wall 27 may form an arc that ranges from approximately 90 degrees toapproximately 180 degrees. The wall may be formed from a transparent ortranslucent material, such as a clear polymer-based material (i.e.,clear plastics, etc.) as are known in the art. Still referring to FIG.1, a support member 30 may extend into the first lumen 24 at the distalend 23 of the first portion 21. The support member 30 may define anaperture 31 that includes a non-circular cross-section configured toreceive the distal end 44 of first shaft 40 (FIG. 2).

Referring to FIG. 2, in an embodiment the present disclosure includes anendoscopic system that includes an endoscope 10 coupled to the distalend 23 of the endoscopic hood 20 of FIG. 1. The endoscope 10 may includean elongate body 12 having a proximal end (not shown), a distal end 16and a working channel 18 extending therethrough. A first shaft 40comprising a proximal end (not shown) and distal end 44 is disposedwithin the working channel 18 of endoscope 10. The distal end 44 offirst shaft 40 is supported by, and slidably disposed within, theaperture 31 of support member 30. A second shaft 50 comprising aproximal end (not shown) and a distal end 54 is disposed alongside theelongate body 12 of endoscope 10. The distal end 54 of second shaft 50extends through, and is slidably and rotationally disposed within, thesecond lumen 25 of endoscopic hood 20. The first and second shafts 40,50 may be formed form a sufficiently flexible and torsionally rigidmaterial that permits the shafts to bend and/or flex as the endoscope isadvanced and/or retracted through a lumen of a patient, while stillbeing able to translate movement to tissue cutting and tissue engagingelements 48, 58 (discussed below). The second shaft 50 may be secured tothe outer surface of the elongate body 12 along the length of theendoscope 10 by one or more clips 62. While the clip 62 of FIG. 2engages a portion of the outer surface of the elongate body 12, avariety of clip configurations are contemplated by the presentdisclosure, including, for example, the fully circumferential clip 62 ofFIG. 7. The distal end 44 of first shaft 40 may include a tissue cuttingelement 48. The tissue cutting element 48 may be a mechanical tissuecutting element, including, for example, a knife, blade, scissors orblunt dissector. The tissue cutting element may be an energy-basedtissue cutting element, including, for example, RF energy, monopolar DCcurrent, bipolar DC current, ultrasonic energy, laser energy, cryogenicenergy or waterjet energy. The distal end 54 of the second shaft 50 mayinclude a tissue engaging element 58, such as, by way of non-limitingexample, a grasper, clip, corkscrew, hook or suction device. The tissuecutting element 48 and tissue engaging element 58 of FIG. 2 are depictedin a delivery configuration which minimizes the profile of theendoscopic system to minimize the risk of perforation upon movementthrough the lumen of a patient. Specifically, the second shaft 50 isrotated such that the tissue engaging element 58 is positioned withinthe working area 29. The first shaft 40 is retracted within the workingchannel 18 of the endoscope 10 with the distal end 44 of the first shaft40 supported within the aperture 31 of the support member 30.

As illustrated in FIGS. 3A-3C, the tissue cutting element 48 and tissueengaging element 58 are configured to operate within the working area 29on the side of the endoscopic hood, rather than beyond the distal end ofthe endoscopic hood as with conventional endoscopic hoods. The distalend 44 of the first shaft 40 may include a shape memory material (e.g.,nitinol, shape memory polymer, heat-set core wire etc.) that assumes abent configuration upon advancing through the first lumen 24 into theworking area 29. For example, the tissue cutting element 48 may assume abent configuration having a predetermined angle of approximately 45degrees to approximately 110 degrees relative to the first shaft 40. Thephysician may extend (FIG. 3B) and/or retract (FIG. 3A) the first shaft40 to vary the position of the tissue cutting element 48 within theworking area 29. The physician may also extend, retract and rotate thetissue engaging element 58 away from and towards the working area 29(FIG. 3C). For example, the tissue engaging element 58 may be used tograsp (i.e., engage, grip, hold etc.) tissues using a rotary lifting ordescending motion and/or a longitudinal push/pull motion to retracttissue away from, or pull tissue into, the tissue cutting element 48.

As best illustrated in FIGS. 3B and 3C, once extended to the desiredlocation within the working area 29, the tissue cutting element 48 isconfigured to move in a sweeping (i.e., side-to-side) or poking motionwithin a single plane. The physician may control the sweeping motion ofthe tissue cutting element 48 by extending and/or retracting anover-sheath (not shown) that retains a portion of the distal end 44 ofthe first shaft 40. The physician may also control the sweeping motionof the tissue cutting element 48 by actuating (i.e., pushing/pulling) acore wire (not shown) that extends the length of the first shaft 40. Thecore wire may include a series of pivot points or segments havingincreased flexibility relative to the remainder of the core wire tofacilitate sweeping of the tissue cutting element 48. Additionaldexterity in tissue cutting may be achieved by simultaneously advancingor retracting the first shaft 40 while sweeping the tissue cuttingelement (i.e., left-to-right and/or right-to-left). Because actuation ofthe tissue cutting and tissue engaging elements 48, 58 is not tied toendoscopic tip articulation, the physician may position the endoscopeover the tissue region of interest and then control the operation of one(or both) both tools using a single hand.

As illustrated in FIGS. 4A-4B, the endoscopic hood may guide the tissuecutting element within the working area using a support member 30 (i.e.,alignment channel) that defines an aperture 31 having a non-circularcross-section. For example, the aperture 31 may be of substantiallycircular cross-section except for a flat portion 31 a. Referring to FIG.4C, the distal end 44 of the first shaft 40 may include a substantiallycircular cross-section having a corresponding flat portion 44 aconfigured to slide within the aperture 31. As illustrated in FIGS.5A-5B, the aperture 31 may be of substantially circular cross-section,except for a recessed portion 31 b. Referring to FIG. 5C, the distal end44 of the first shaft 40 may include a substantially circularcross-section having a corresponding raised portion 44 b (FIG. 5C)configured to slide within the aperture 31. In either embodiment, thenon-circular configuration of the aperture 31 ensures that the tissuecutting element 48 is aligned within working area 29 in a single plane.Unlike conventional devices that guide tools through multiple planes,the endoscopic hood 20 of the present disclosure may provide increasedcontrol of tissue manipulation by controlling the tissue cutting element48 in a single plane.

The transparent (i.e., clear) wall 27 and large working area 29 of theendoscopic hood 20 provide the physician with a large and unobstructedfield of view that is not possible with fully circumferential endoscopichoods. Referring to FIG. 6, the proximal ends 42, 52 of the first andsecond shafts 40, 50 may be actuated using a handle 60 at the proximalend 14 of the endoscope 10. The ability of the physician tosimultaneously manipulate the tissue cutting element 48 and tissueengaging element 58 using separate motions that require few degrees ofmotion and which are not tied to endoscope tip articulation allowstissue resection or dissection to be performed with increased speed andprecision. Although endoscopic tip articulation is only required fornavigating and positioning the tissue cutting element 48 and tissueengaging element 58 over a target tissue, it should be appreciated thatthe curved shape of the wall 27 of the endoscopic hood 20 may be used topress against tissues as necessary during the medical procedure. Forexample, the physician may articulate the endoscope such that the curvedwall 27 presses against a portion of the tissue, thereby raising and/orexposing another portion of the tissue for grasping and or cutting usingthe respective tools.

All of the devices and/or methods disclosed and claimed herein can bemade and executed without undue experimentation in light of the presentdisclosure. While the devices and methods of this disclosure have beendescribed in terms of preferred embodiments, it may be apparent to thoseof skill in the art that variations can be applied to the devices and/ormethods and in the steps or in the sequence of steps of the methoddescribed herein without departing from the concept, spirit and scope ofthe disclosure. All such similar substitutes and modifications apparentto those skilled in the art are deemed to be within the spirit, scopeand concept of the disclosure as defined by the appended claims.

What is claimed is:
 1. A hood configured to be disposed about a distalend of an endoscope, the endoscope comprising an elongate body and aworking channel disposed within the body, the hood comprising: a firstportion comprising a proximal end, a distal end and first and secondlumens extending therebetween; and a second portion comprising a curvedwall extending distally from the distal end of the first portion, thecurved wall defining a working area adjacent a concave surface of thecurved wall and the first lumen; wherein the first lumen is configuredto receive a portion of a first device inserted along the workingchannel of the endoscope, and wherein the second lumen is external tothe second portion and is configured to slidably and rotationallyreceive a portion of a second device along an outer surface of theendoscope, the second portion being configured for a portion of thesecond device to be positionable within the working area by beingrotated about a longitudinal axis of the second lumen.
 2. The hood ofclaim 1, wherein the curved wall comprises one of a partial hollow conicsection or a partial hollow cylinder.
 3. The hood of claim 1, wherein across-section of the curved wall forms an arc as a portion of a circle.4. The hood of claim 3, wherein an angle of the arc about the circleranges from approximately 90 degrees to approximately 180 degrees. 5.The hood of claim 1, wherein the curved wall has an open distal end. 6.An endoscopic system comprising: an endoscope comprising an elongatebody having a proximal end, a distal end, and a working channel disposedwithin the elongate body; a hood coupled to the distal end of theendoscope, the hood comprising: a first portion comprising a proximalend, a distal end, and first and second lumens extending therebetween,wherein the first lumen is in communication with the working channel ofthe endoscope; a second portion extending from the distal end of thefirst portion defining a working area adjacent a surface of the secondportion and the first lumen; and a support member extending with thefirst lumen, the support member defining a non-circular apertureadjacent to the second portion; a first device having a proximal end anda distal end, the first device insertable through the working channeland the first lumen; and a second device having a proximal end and adistal end, the second device slidably and rotationally extendable alongan outer surface of the elongate body and through the second lumen, thesecond device rotatable about a longitudinal axis of the second lumeninto and out of the working area; wherein the second lumen is externalto the second portion.
 7. The endoscopic system of claim 6, wherein thefirst device comprises a non-circular cross-section that substantiallymatches a cross-section of the non-circular aperture.
 8. The endoscopicsystem of claim 6, wherein the non-circular aperture includes a recessedportion.
 9. The endoscopic system of claim 6, wherein the non-circularaperture includes a flat portion.
 10. The endoscopic system of claim 6,wherein the non-circular aperture of the support member is configured toprevent rotation of the first device.
 11. The endoscopic system of claim10, wherein the non-circular aperture is configured to restrictarticulation of the first device to a single longitudinal plane.
 12. Theendoscopic system of claim 6, wherein the non-circular aperture of thesupport member is configured to slidably receive the first device. 13.The endoscopic system of claim 6, wherein the support member extendsfrom the first portion radially within the first lumen.
 14. Theendoscopic system of claim 6, wherein the support member issubstantially axially aligned with the second portion.
 15. Theendoscopic system of claim 6, wherein the distal end of the seconddevice is bent with respect to the longitudinal axis of the seconddevice and the second lumen.
 16. A method of treating tissue,comprising: a) inserting an endoscope into a body of a patient, theendoscope comprising a working channel extending within the elongatebody and a hood coupled to a distal end of the endoscope, the hoodcomprising: a first portion having first and second through-lumens, thefirst lumen in communication with the working channel; a second portionextending from the distal end of the first portion defining a workingarea adjacent a surface of the second portion and the first lumen; and asupport member defining a non-circular aperture extending into the firstlumen; wherein the second lumen is external to the second portion; b)inserting a first device within the working channel and through thefirst lumen, the first device including a distal tissue cutting element;and c) extending a second device along an outer surface of the elongatebody and through the second lumen, the second device including a distaltissue engaging element; d) positioning the hood over the surface of atarget tissue; e) rotating the second device about a longitudinal axisof the second lumen of the hood and into the working area; and f)excising a portion of the tissue with said tissue cutting element whileengaging the tissue with said tissue engaging element.
 17. The method ofclaim 16, wherein the non-circular aperture of the support member isconfigured to slidably receive the first device.
 18. The method of claim17, wherein the non-circular aperture is configured to restrict thefirst device to articulating in a single longitudinal plane.
 19. Themethod of claim 16, wherein the first device comprises a non-circularcross-section that substantially matches the non-circular aperture. 20.The method of claim 16, wherein the second portion comprises a curvedwall.